MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA HELICAL BLADE 80MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.280S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Date of device migration is not known.(b)(4).Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Dhr review for part # 04.038.280s lot # h207885.Release to warehouse date: 28 october 2016.Expiration date: 30 september 2026.Manufacturing site: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 80mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient had a trochanteric fixation nail-advanced (tfna) proximal femoral nail procedure on (b)(6) 2017 to treat a hip fracture and it was noted on post-operative x-rays that the helical blade migrated out of the nail.On (b)(6) 2017 the patient presented to the hospital with a hip fracture that was confirmed by x-ray.The tfna surgery was completed and the surgeon was pleased with the fracture fixations.On (b)(6) 2017 the patient had a follow up clinic visit.An x-ray taken at the visit confirmed the helical blade had migrated out a few millimeters.Additional clinic follow up was recommended.The patient had an office visit on (b)(6) 2017 and x-rays confirmed the helical blade had completely migrated out of the nail and was immediately lateral to the nail in the patient tissue.It is unknown if the patient had pain or discomfort related to this event.The patient¿s x-rays were shown during fracture conference on (b)(6) 2017.No decision was immediately made to fix the issue.The surgeon reported locking the helical blade all the way to the static position and then turning the locking mechanism a 1/2 turn off, per the technique guide, for guided collapse.Concomitant devices reported: tfna nail (04.037.157s, lot number h184921, quantity 1), 5.0 titanium screw 46mm (part 04.005.536s, lot h207885, quantity 1).This report is for one (1) tfna helical blade 80mm.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 80MM STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6962829
• MDR Text Key: 89814086
• Report Number: 3003506883-2017-10240
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.280S
• Device Lot Number: H207885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 73